The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Disposable Catheter.
Device ID | K860882 |
510k Number | K860882 |
Device Name: | DISPOSABLE CATHETER |
Classification | Connector, Airway (extension) |
Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota, NY 13032 |
Contact | Ronald N Mchenry |
Correspondent | Ronald N Mchenry DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota, NY 13032 |
Product Code | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-25 |
Decision Date | 1986-03-20 |